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NCT Number: NCT06012097

Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease

De Quervain disease is characterized by an adductor pollicis longus and extensor pollicis brevis tendons inflammation as thys pass beneath the extensor retinaculum at the radial styloid. This pathology is recognized as a musculoskeletal disorder of the upper limb triggering functional deficits resulting to possible modifications in the professional activity, sources of absenteeism, thus constituting an economic cost for society. At the etiological level, this pathology also affects young mothers (it's called "mother's wrist" or mommy thumb"), mobile phone users ("textonite", "Blackberryte") or video game players ("Nintendoite").

Currently, the treatment is mainly conservative by splint and anti-inflammatory gel and/or corticosteroid infiltration. Howewer, these therapies have undesirable effects. The interest of this study is therefore to propose another therapy based on aromatherapy gel.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service SOS Main

Strasbourg, 67000, France

Location status: Recruiting

Location contact

Sybille FACCA

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patient aged 18 to 75,
  • Patient with unilateral De Quervain's tenosynovitis,
  • Patient cared in the Hand Surgery Department, SOS Mains Emergency Department or Rheumatology Department of Strasbourg University Hospitals,
  • Patient informed of the results of the prior medical examination,
  • Informed consent signed by the patient,
  • Patient affiliated to a health insurance social protection scheme or beneficiary,
  • For a woman of childbearing potential, negative urine pregnancy test at the inclusion visit and maintenance of effective contraception throughout the study.

Exclusion criteria

  • Pregnant or breastfeeding patient,
  • Patient allergic to a component of the gel with essential oils, Dicloflenac®, NSAIDs, or one of the excipients
  • Patient treated with oral non-steroidal anti-inflammatory drugs
  • Patient with ongoing treatment with another ointment at the treatment application site (radial edge of the wrist)
  • Patient with damaged skin, whatever the lesion: oozing dermatosis, eczema, infected lesion, burn or wound,
  • Patient with atopic skin disease,
  • Patient with epilepsy or with a history of epilepsy,
  • Patient with a history of homolateral De Quervain's tenosynovitis, or having already had corticosteroid infiltrations in the 6 months before his inclusion on the ipsilateral side of the pathology,
  • Patient with associated tendinopathies in the elbow or forearm region,
  • Impossibility of giving the patient information (patient in an emergency situation, patient with difficulties of understandin, agitation of the patient),
  • Patient under legal protection, under guardianship or curatorship.

Treatment and study plan

Diclofenac Gel

Drug

using diclofenac as a comparator

Aromatherapy gel

Drug

using Aromatherapy gel as an experimetnal treatment

Primary outcomes

  1. Measure of pain during the WHAT test

    Time frame: Day 0

    Visual analogue pain scale (quotation between 0 and 10) during WHAT Test

  2. Measure of pain during the WHAT test

    Time frame: Day 42

    Visual analogue pain scale (quotation between 0 and 10) during WHAT Test

  3. Measure of pain during the WHAT test

    Time frame: Day 84

    Visual analogue pain scale (quotation between 0 and 10) during WHAT Test

Study contacts

Contact information is provided by the study sponsor or research team.

Marie SCHWEBEL

CONTACT

[email protected]

03 68 76 53 40

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease : Monocentric Study, Controlled, Randomized, Partially Blinded, in Paralleled Groups

Acronym: Helping Hand

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2023
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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